【摘要】 目的:评估国产度洛西汀肠溶片(奥思平)治疗单相抑郁症的疗效和安全性。方法:60例符合入组标准的患者随机接受国产度洛西汀肠溶片(奥思平组)和进口度洛西汀肠溶胶囊(欣百达组)治疗,每组30例,平均剂量分别为51.13mg/d和57.35mg/d,观察疗程为6周。采用汉密顿抑郁量表(HAMD)进行疗效评估,用治疗中出现的症状量表(TESS)、血生化指标、心电图和体质量改变等进行安全性评估。结果:奥思平组患者的有效率为86.21%,欣百达组为89.64%,两组比较,差异无统计学意义(P>0.05),HAMD总分及各因子分减分率两组之间差异无统计学意义(P>0.05)。奥思平不良事件的发生率为65.52%,欣百达为58.62%,差异无统计学意义(P>0.05)。结论:奥思平治疗单相抑郁症的疗效与欣百达相当,安全性良好。更多还原

【Abstract】 Objective: To evaluate the efficacy and safety of the domestic duloxetine (aosiping) in treatment of depression. Method: All 60 patients who met enrolled criteria were randomly assigned to domestic duloxetine (aosiping group,n = 30) or import duloxetine (cymbalta group,n = 30) treatment for 6 weeks,and the averaged dosage is 51. 13 mg/d and 57. 35 mg/d respectively. The efficacy was evaluated with the Hamilton depression scale (HAMD) . The safety was assessed with the treatment emergent symptom scale(TESS) ,changes of biochemical index,electrocardiogram and weight. Results: The response rates were 86. 21% in aosiping group and 89. 64% in cymbalta group. There were no statistically significant differences between the two groups. There were no statistically significant differences with regard to reduction in HAMD total scores between the two groups(P > 0. 05) . Incidence of adverse events was 65. 52% in aosiping group and 58. 62% in cymbalta group. There were no statistically significant differences between the two groups(P > 0. 05) . Conclusion: The results show that domestic duloxetine (aosiping) has similar therapeutic effect to cymbalta in treatment of depression, it is safe and generally well-tolerated.更多还原